View clinical trials related to Peritoneal Dialysis.
Filter by:This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.
A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis. A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups.
The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD). The main objective is: • To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease Secondary objectives are: • To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks. Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels.
The aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Forty patients from peritoneal dialysis centers will randomly assign to either Melatonin or placebo group. The patients in Melatonin group will receive 5 mg Melatonin (as 1 tablet) daily for 10 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; Procollagen 1 Intact N-Terminal Propeptide; Tartrate-resistant acid phosphatase 5b; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; and also systolic blood pressure; diastolic blood pressure and questionnaires including quality of life; quality of sleep and depression will be assessed.
Background: The patient presenting Chronic Kidney Disease, with etiology of diabetes mellitus (DM), has a metabolic alteration characterized by an elevation of glycemia and accompanied by cardiovascular complications, this increases the morbidity and mortality associated with the disease. Therefore, it is necessary to maintain adequate metabolic control to reduce the incidence of these complications. This task is extraordinarily difficult without the use of Icodextrin due to the optimal adjustment of insulin, due to the additional supply of glucose contained in the Dialysis Bosas and which is absorbed through the peritoneum. Under this premise, it is of utmost importance the surveillance of the patient through constant glycemic monitoring to provide an overview of the metabolic status of our patients, this will allow clinically relevant data to improve care, minimize expenses in the health system and implement measures for decision making in the adjustment of dialysis treatment. Objective: To use continuous glucose monitoring to detect whether the type, dose, route of administration and timing of insulin application are associated with the patterns provided by continuous glucose monitoring (magnitude and duration of periods of hyper and/or hypoglycemia) in 24-hour periods of tissue glucose. Material and methods: This is a cross-sectional, non-interventional study in adult patients with Type 2 Diabetes Mellitus on Peritoneal Dialysis in its Automated modality who present high and high average peritoneal transport type. As inclusion criteria, participants over 40 years of age, of any sex, diagnosed with Diabetic Nephropathy, and who are insulin-dependent for metabolic control, with at least three months of PD treatment. The project will consist of evaluating the patient's glycemic control continuously, with an automatic scan and data recording every six hours during the infusion time of Automated Peritoneal Dialysis. For this, 110 patients are required according to the sample size. The Guardian TM 3 Sensor will be placed using the One PressTM Grafter subcutaneously in the upper posterior region of the patient's non-dominant arm, it is a minimally invasive procedure that does not require surgical protocols. This sensor will be connected to the Guardian Connect Transmitter for continuous communication with the Guardian™ Connect (App). The sensor has an approximate life of 7 days (time that lasts the enzymatic reaction and that allows an adequate measurement) the data will be transmitted every five minutes 24 hours a day, for 7 consecutive days. The patient will be scheduled at the end of these days to place a second sensor and complete the 14 days of follow-up. On day seven, the patient will be scheduled for sensor removal, and a new one will be placed to complete 14 days of follow-up. On day 14, the total 24-hour PD drainage volume will be recovered for a glucose, urea and creatinine measurement and peritoneal glucose absorption, D/P creatinine and Kt/V will be calculated. The dietary information will be obtained for the calculation of calorie intake and meal time; it is together with the subcutaneous application of insulin will be recorded within the same GuardianTM Connect (App). Statistical analysis: The databases will be audited in monthly periods by random sampling in blocks of 5% of their content. Semi-annual reports will be integrated with the monitoring of the records achieved and the outcomes to date of the reports. The reports will contain the basic descriptive information (central tendency and dispersion) according to the characteristics of the variables. Patients will be classified according to the time of glucose measurements within the pre-established ranges (70-180 mg / dL), the goal is that 70% of the time they are in that range and will be called "Adequate" and those who do not reach the goal will be called "Not Adequate". The results will be reported with measures of central tendency and dispersion appropriate to the characteristics of the variables. For the detection of difference between the appropriate and inappropriate group, the Chi square statistic or the Student's T or Mann-Whitney U will be used according to the type of variables. For the association analysis that allows detecting the variables of greatest influence on glycemic control in the recommended ranges with continuous glucose monitoring, logistic regression analysis will be used. In a first stage, analysis will be done by independent variable and in a second stage, a multivariate analysis will be made, where the type of insulin, the route of administration, the dose and the schedules will be considered. At this stage, confounding variables will also be included, such as; obesity, adherence to treatment and diet and physical activity prescribed by the treating physician.
This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.
The goal of this observational study is to compare hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are: - What is the level of physical activity in hemodialysis and peritoneal dialysis patients? - What is the level of quality of life of hemodialysis and peritoneal dialysis patients? - Is there any relation between inactivity and quality of life in hemodialysis and peritoneal dialysis patients? Participants will answer 2 questionnaires and will do some functional tests.
We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis. The main questions are: - The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis. - The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of peritonitis, the incidence of anuria, the first incidence of hospitalization, technical failure, all cause mortality, cardiovascular disease free survival and the quality of life. Participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis. An extracellular water /total body water (ECW/TBW) ≥ 0.40 or edema is defined as overhydration (OH). The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW < 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW < 0.40 or edema disappeared. Researchers will compare the time of transferring from low dose PD to full dose and the clinical outcomes in the first year between the patients in ICO and CON groups to see the effect of icodextrin on the shift of low dose to full dose dialysis and clinical outcomes in the first year in patients on incremental peritoneal dialysis. Successful completion of the study will advance our strategy of incremental PD and help to prolong the shift from incremental to full dose dialysis, and offer new opportunities for the development of an effective and economical therapy for PD patients with residual kidney function (RKF)
The goal of this prospective, observational, multicentre cohort study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQOL) of informal caregivers of patients who start home dialysis, and compare these to experiences and HRQOL of informal caregivers of patients who start in-centre hemodialysis. The investigators hypothesise that informal caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.
Background: Continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are two important PD modalities. To date, only three small sample randomized control trials(RCTs) comparing CAPD and APD have been conducted but yield inconsistent results. Objective: Investigators plan to initiate a multicenter, prospective, randomized cross-over study to compare the quality of life and dialysis adequacy in non-diabetic PD patients. Hypothesis: Patients' quality of life and dialysis adequacy on APD is no worse than on CAPD. Methods: This study plans to recruit 268 non-diabetic patients on maintenance peritoneal dialysis. Patients will randomly be assigned into groups A and B in a 1:1 ratio: group A receives APD from week 1 to 12 and changes to CAPD from week 13 to 24; group B receives CAPD from week 1 to 12 and changes to APD from week 13 to 24. Outcomes were evaluated at week 12 and week 24.